FE C TAB - iron pentacarbonyl and ascorbic acid tablet
Boca Pharmacal, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FE C Tab

Supplement Facts Serving Size 1 Tablet
Amount Per Tablet	% Daily Value
Iron (as Carbonyl Iron)	100 mg 556%
Vitamin C (as Ascorbic Acid)	250 mg 417%

Inactive Ingredients Include: Microcrystalline Cellulose, Dicalcium Phosphate, Silicon Dioxide, Stearic Acid, Magnesium Stearate, Hypromellose, Polyethylene Glycol, FD & C Yellow #6 Aluminum Lake, Mineral Oil, Talc, Titanium Dioxide.

STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F)

DIRECTIONS: Adults and Children 12 years and over – One tablet daily or as directed by a physician. Children under 12 years: Consult a physician.

WARNINGS:

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron products may occasionally cause constipation or diarrhea. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose call a doctor or poison control center immediately.

DO NOT ACCEPT IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

Manufactured for: Boca Pharmacal, Inc. Coral Springs, FL 33065
www.bocapharmacal.com Rev. 06/09 077T

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

[Rev. 3]

FE C TAB
iron, vitamin c tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:64376-803
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON PENTACARBONYL (IRON PENTACARBONYL)	IRON PENTACARBONYL	100 mg
ASCORBIC ACID (ASCORBIC ACID)	ASCORBIC ACID	250 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
HYPROMELLOSES
FD&C YELLOW NO. 6
CELLULOSE, MICROCRYSTALLINE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
MINERAL OIL

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:64376-803-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/19/2010

Labeler - Boca Pharmacal, Inc. (170266089)

Registrant - Boca Pharmacal, Inc. (170266089)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	MANUFACTURE(64376-803)

Revised: 08/2012

Document Id: 09689a22-0d5f-4edd-98c0-cb0dd70a87b9

Set id: c81325e0-c2db-4412-89a9-236a6733f229

Version: 1

Effective Time: 20120802

Boca Pharmacal, Inc.